A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease

Phase 2

Completed

• Conditions: Hodgkin's Disease
• Interventions: Drug: MDX-060

• Registration Number: NCT00284804
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.

Detailed Description

Secondary objectives include:

* to characterize progression-free survival

* to characterize time to progression

* to determine response duration

* to characterize the effect of study drug on health-related quality of life

* to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population

* to characterize the immunogenicity response of MDX-060

* to characterize the safety of MDX-060, and

* to characterize the pharmacokinetic profile of MDX-060

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-01-30
• Study First Submitted QC: 2006-01-30
• Study First Posted: 2006-02-01
• Primary Completion: 2008-05
• Study Completion: 2009-10
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Diagnosis of Hodgkin's disease [HD] (excluding HIV-associated HD)
• Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
• Patients must have failed or relapsed following second line (i.e., salvage) chemotherapy or relapsed or failed following autologous stem cell transplant
• ECOG Performance Status of 0-2
• Patients must have bi-measurable disease
• At least 4 weeks since the last chemotherapy or radiation therapy with clinical evidence of recovery from any toxicity associated with such treatment
• Life expectancy 12 weeks or greater
• Screening laboratory values must be met
• Patients on corticosteroids must be tapered off the medication 2 weeks prior to study drug administration and remain off corticosteroids until study completion.

Exclusion Criteria

• Previous treatment with any anti-CD30 antibody
• History of allogeneic transplant
• Any tumor lesion 10cm or greater in diameter
• Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
• Any significant active or chronic infection
• Apparent active or latent tuberculosis (TB) infection
• Patients who are pregnant or nursing
• Any underlying medical condition which, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
• Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MDX-060 plus standard of care	MDX-060	MDX-060 in combination with gemcitabine
Standard of care	MDX-060	Gemcitabine

Primary Outcome Measures

Name	Time	Method
Overall response rate	Day 50/57

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Day 50/57

Trial Locations

Locations (17)

Mary Babb Randolph Cancer Center; 🇺🇸 Morgantown, West Virginia, United States

California Oncology of the Central Valley; 🇺🇸 Fresno, California, United States

American Health Network of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Division of Hematology/Oncology, Tufts-New England Medical Center; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Nevada Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States

M.D. Anderson Cancer Center, The University of Texas; 🇺🇸 Houston, Texas, United States

H. Lee Moffitt Cancer & Research Institute; 🇺🇸 Tampa, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

City of Hope, National Medical Center; 🇺🇸 Duarte, California, United States

Rush Cancer Institute; 🇺🇸 Chicago, Illinois, United States

St. Francis Hospital Center; 🇺🇸 Beech Grove, Indiana, United States

The Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Roswell Park Cancer Center; 🇺🇸 Buffalo, New York, United States

Carolina BioOncology Institute, PLLC; 🇺🇸 Huntersville, North Carolina, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

University of California, San Diego/Moores UCSD Cancer Center; 🇺🇸 LaJolla, California, United States